How Clinical Evaluations are evolving
Since the publication of the draft of “ISO 18969: Clinical Evaluation of Medical Devices” in December 2025, there has been a lot of speculation of what this will mean for manufacturers, writers, consultants and Notified Bodies.
This white paper aims to highlight what differences should be noted between the different frameworks and clarifying where differences may affect current clinical evaluation practices.
As this ISO standard is still in the draft stage, this white paper will be updated until full publication, using the changes across the revisions as a way to acknowledge and document the work that goes into creating a standard.
